FRONT RADIUS CUTTER— 510(k) K841620

Name: FDA 510(k) clearance K841620
Creator: U.S. Food and Drug Administration
Published: 1984-09-20

Substantially Equivalent

Plastafil, Inc.

FDA 510(k) clearance K841620 for FRONT RADIUS CUTTER, Substantially Equivalent on 1984-09-20. Applicant: Plastafil, Inc.. Device class: 1.

Clearance details

Applicant: Plastafil, Inc.
Product code: Code HTX
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1984-04-19
Decision date: 1984-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K874954 — MANUAL RONGEUR1987-12-30
K841621 — BACK RADIUS CUTTER1984-09-20
K780397 — ORTHOPEDIC FORCEPS1978-03-22
K760325 — SURGICAL INSTRUMENTS, ORTHOPEDIC1976-08-03

More clearances from Plastafil, Inc.

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Adverse events under product code HTX

product code HTX

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.